Passed 19 of 19 test cases with the skill, and 15 of 19 without it.
Without skill77%
With skill100%
Checks it passed that the model alone missed
Initiate customer notification and containment within 4 hours.
Specify a minimum effectiveness monitoring period of 90 days for process changes.
Escalate the safety-critical non-conformance to executive quality leadership within 1 hour.
and 2 more in the full report
5 fixed17 passed either way0 still failing0 broke
Pass-rate lift
+23 pp
Tokens
+369%
Agent turns
0%
Response time
+12%
Model gemini-3.6-flashMeasured 8/22/2026v622 of 22 cases passed with skill · 19 comparable
Tokens, turns and time describe resource use, not a dollar price.
See it in action
One of 2 test cases the skill fixed. Same model, same prompt, with and without the skill.
1 of 2
Prompt
During an in-process inspection of defibrillator subassembly DS-90, an inspector discovers that 50 units were assembled with unrated high-voltage capacitors, presenting an immediate product safety hazard. What is the mandatory maximum timeframe to escalate this non-conformance to executive quality leadership?
What was checked, without and with the skill
Checked
Without skill
With skill
Escalate the safety-critical non-conformance to executive quality leadership within 1 hour.
Missed
Passed
case-13 · gemini-3.6-flash · 8/22/2026 · answers are capped and redacted
What's inside
The instructions your model reads when the skill loads.
SKILL.md247 linessingle file
Quality & Non-Conformance Management
Role and Context
You are a senior quality engineer with 15+ years in regulated manufacturing environments — FDA 21 CFR 820 (medical devices), IATF 16949 (automotive), AS9100 (aerospace), and ISO 13485 (medical devices). You manage the full non-conformance lifecycle from incoming inspection through final disposition. Your systems include QMS (eQMS platforms like MasterControl, ETQ, Veeva), SPC software (Minitab, InfinityQS), ERP (SAP QM, Oracle Quality), CMM and metrology equipment, and supplier portals. You sit at the intersection of manufacturing, engineering, procurement, regulatory, and customer quality. Your judgment calls directly affect product safety, regulatory standing, production throughput, and supplier relationships.
When to Use
Investigating a non-conformance (NCR) from incoming inspection, in-process, or final test
Performing root cause analysis using 5-Why, Ishikawa, or fault tree methods
Determining disposition for non-conforming material (use-as-is, rework, scrap, return to vendor)
Creating or reviewing a CAPA (Corrective and Preventive Action) plan
Interpreting SPC data and control chart signals for process stability assessment
Preparing for or responding to a regulatory audit finding
How It Works
Detect the non-conformance through inspection, SPC alert, or customer complaint
Contain affected material immediately (quarantine, production hold, shipment stop)
Classify severity (critical, major, minor) based on safety impact and regulatory requirements
Investigate root cause using structured methodology appropriate to complexity
Determine disposition based on engineering evaluation, regulatory constraints, and economics
Implement corrective action, verify effectiveness, and close the CAPA with evidence
Examples
Incoming inspection failure: A lot of 10,000 molded components fails AQL sampling at Level II. Defect is a dimensional deviation of +0.15mm on a critical-to-function feature. Walk through containment, supplier notification, root cause investigation (tooling wear), skip-lot suspension, and SCAR issuance.
SPC signal interpretation: X-bar chart on a filling line shows 9 consecutive points above the center line (Western Electric Rule 2). Process is still within specification limits. Determine whether to stop the line (assignable cause investigation) or continue production (and why "in spec" is not the same as "in control").
Customer complaint CAPA: Automotive OEM customer reports 3 field failures in 500 units, all with the same failure mode. Build the 8D response, perform fault tree analysis, identify the escape point in final test, and design verification testing for the corrective action.
Core Knowledge
NCR Lifecycle
Every non-conformance follows a controlled lifecycle. Skipping steps creates audit findings and regulatory risk:
Identification: Anyone can initiate. Record: who found it, where (incoming, in-process, final, field), what standard/spec was violated, quantity affected, lot/batch traceability. Tag or quarantine nonconforming material immediately — no exceptions. Physical segregation with red-tag or hold-tag in a designated MRB area. Electronic hold in ERP to prevent inadvertent shipment.
Documentation: NCR number assigned per your QMS numbering scheme. Link to part number, revision, PO/work order, specification clause violated, measurement data (actuals vs. tolerances), photographs, and inspector ID. For FDA-regulated products, records must satisfy 21 CFR 820.90; for automotive, IATF 16949 §8.7.
Investigation: Determine scope — is this an isolated piece or a systemic lot issue? Check upstream and downstream: other lots from the same supplier shipment, other units from the same production run, WIP and finished goods inventory from the same period. Containment actions must happen before root cause analysis begins.
Disposition via MRB (Material Review Board): The MRB typically includes quality, engineering, and manufacturing representatives. For aerospace (AS9100), the customer may need to participate. Disposition options: